Hepatitis B virus genotyping detection reagent kit (PCR-fluorescence method)
- Device class
- Class III
- Model specifications
- Serves 32 per box32人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20173400439
- Approval date
- August 06, 2021
- Expiry date
- August 05, 2026
- Name
- Shanghai Fosun LONG March MEDICAL Science Co., Ltd.复星诊断科技（上海）有限公司
- Province/Region
- Shanghai上海
- Address
- 830 Chengyin Road, Baoshan District, Shanghai上海市宝山区城银路830号
- Production address
- 上海市宝山区城银路830号
This product is used for the qualitative detection of hepatitis B and C viruses in the serum of hepatitis B patients.
该产品用于定性检测乙型肝炎患者血清中B、C型乙型肝炎病毒。
Nucleic acid extract A, nucleic acid extract B, PCR buffer, B-type probe, C-type probe, Taq enzyme, B/C strong positive control, type B positive serum control, type C positive serum control, negative control. (Please refer to the manual for details)
核酸提取液A、核酸提取液B、PCR缓冲液、B型探针、C型探针、Taq酶、B/C强阳性对照、B型阳性血清对照、C型阳性血清对照、阴性对照。（具体内容详见说明书）
Store at -20 °C with a valid date of 12 months.
-20℃保存，有效期为12个月。
- Remark
- 延续注册产品技术要求未发生变化，沿用原核发的产品技术要求。
- Changes
- 2021-06-18 “注册人名称:上海复星长征医学科学有限公司”变更为“注册人名称:复星诊断科技（上海）有限公司”。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Hepatitis B virus genotyping detection reagent kit (PCR-fluorescence method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20173400439 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on August 06, 2021.
This page provides complete registration details including registrant information, province location (Shanghai), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.